FDA EMDAC Recommends Approval of Lomitapide for Treatment of Homozygous Familial Hypercholesterolemia (HoFH)

Aegerion Pharmaceuticals AEGR announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) determined by a vote of 13 to 2 that Aegerion has presented sufficient safety and efficacy data to support marketing of its product, lomitapide, for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH) when used as an adjunct to a low-fat diet and other lipid-lowering therapies. "Today's Advisory Committee recommendation is an important milestone in our mission to provide patients with HoFH with urgently needed new treatment options to lower their cholesterol levels," said Marc Beer, Chief Executive Officer of Aegerion Pharmaceuticals. "We look forward to continuing to work closely with the FDA as the agency completes its review of our new drug application for lomitapide." The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 29, 2012, for completion of its review of the New Drug Application (NDA) for lomitapide. The EMDAC provides the FDA with independent expert advice and recommendations. The FDA See full press release